The present invention relates in general to protective devices for intravenous (IV) needles which are inserted into a patient's vein, such as sleeves and covers. The present invention also relates to bands and straps used to secure and retain IV needles and the connecting tube to the needle.
More particularly the present invention relates to single devices which protect the IV needle from contamination while stabilizing the needle and connecting tube so that they cannot pull free from the patient's vein.
Intravenous needles provide a means to gradually inject liquids into a patient's vein. While the type of liquid may vary as will the reason for intravenous delivery, the basic structure and insertion into the patient is normally the same. The needle hub is connected to one end of a delivery tube and the opposite end of the delivery tube is connected to a reservoir supply of liquid. The rate of delivery from the reservoir supply can be controlled so as to achieve a desired volumetric flow rate for the particular patient and the particular liquid being administered. While occasionally the insertion of the needle into the patient's vein may be a hit or miss proposition, the nurse or other medical personnel eventually gets the needle properly inserted. Next the delivery tube is secured to the anatomy of the patient with adhesive tape in order to try and relieve any stress on the needle and to try to prevent or at least reduce the risk of the needle pulling out from the vein if the tube is pulled or catches on some object. In this normal arrangement, the needle is exposed to the atmosphere, except for the portion inserted into the vein, and thus any dirt, fluids or debris could contaminate the needle and tube at the site of insertion. In this arrangement there is also some discomfort associated with removal of the needle due to placing adhesive tape directly against the patient's skin.
Over the years others have attempted to design stabilizing bands for IV needles and the associated tube as well for holding and protecting the IV needles. Representative of some of these earlier attempts are the devices disclosed in the following issued patents:
______________________________________ PATENT NO. PATENTEE ISSUE DATE ______________________________________ 4,591,356 Christie May 27, 1986 4,822,342 Brawner April 18, 1989 4,898,587 Mera February 6, 1990 3,900,026 Wagner August 19, 1975 4,870,976 Denny October 3, 1989 ______________________________________
Christie discloses an intravenous needle stabilizing band which wraps around the arm of the patient. The exterior surface of the band includes opposing flaps which open to permit passage over the tube part of the needle and means to secure the tube in place directly onto the exterior surface of the band.
Brawner discloses a prepared tape for a body inserted tube, such as an intravenous needle. The device includes a multi-layer arrangement typically involving two separate portions as is illustrated in FIG. 4 for clamping the hub of the needle and for securing the delivery tube. In this instance as has been explained in the background discussion, the tape goes directly to the patient's skin and portions of the needle as well as the delivery tube are both exposed to the atmosphere and create surfaces which may be caught or pulled with normal movement.
Mera discloses an intravenous line stabilizing device configured as a two-part clamping arrangement which has a specifically contoured shape to provide a clearance slot for the needle hub and a channel for the tube. Once the base plate is secured directly to the patient's arm the needle hub and tube are laid into position and a top cover or clamping plate is placed on top. A second clamp is used to secure the tube to the arm of the patient and the run of tubing up the arm from the needle location to this securing clamp location is open and free to be caught or pulled by movement of the hand thereby running the risk that the needle could be pulled loose from the vein.
Wagner discloses a somewhat complicated device for holding and protecting intravenous injection needles. As is illustrated in FIGS. 1 and 2, there is a cap member 15 which is applied directly to the arm and has an angled neck portion 17 for securing the needle hub and tube in an inclined and upwardly elevated orientation. All of the attention of this reference is directed to maintaining some angularity of the needle and stabilizing the needle hub without regard to the tube or where the tube will run. Consequently, as the loose tube is allowed to move freely there is a chance that it would be caught or pulled by some object within the patient's room or wherever the patient may be moving. If the tube is caught, the needle could be jarred loose or at least create substantial discomfort for the patient.
Denny discloses a very elaborate intravenous injection shield assembly which includes a protective shield member made of a rigid transparent plastic. The assembly further includes strap members for holding the assembly in a predetermined position on a limb and defines a clearance space which is suitable to receive an intravenous needle and tubing. The disclosed design is somewhat complex with a number of straps and ties which must be completed as well as having substantial size and weight and clearly not providing the type of device which could be easily applied and removed.
While some of the structural concepts of these listed references relate to stabilizing the needle and tube and while some references disclose partial covering of the needle, none are believed to anticipate the present invention. Further, the simplicity of the present invention and the additional enhancements provided would not have been obvious in view of the above-listed references. Additionally, the listed references all pertain to insertion of the needle into a vein in a patient's arm or back of the hand adjacent the wrist. What is not disclosed and what each device that is disclosed in the listed references is not suitable for is to stablize and protect the needle and tube when the needle is inserted into the vicinity of the metacarpo-phalangeal joint. The difficulty with this area is the extent of flexing of the fingers and hand for performing basic mechanical motions such as when eating. There is not a suitably flat stationary surface adjacent the point of insertion of the needle to utilize devices such as that disclosed in Mera which need a flat stationary surface for the designed method of attachment. Although Mera describes its base plate 12 as being of a moderately pliable plastic, its pliability is directed only to contouring to the skin. There is no suggestion that this base plate will stretch in length so as to conform to the stretched skin over the metacarpo-phalangeal joint during maximum flexing (closing) of the hand. In contrast, the present invention discloses a design embodiment which is suitable for IV needles inserted into the area of the hand adjacent the metacarpo-phalangeal joint.